Shares of Alnylam Inc. (ALNY - Free Report) have soared 61.2% year to date compared with the industry’s growth of 8.8%. Let us look at some of the factors backing the surge.
In November, the FDA approved givosiran injection for subcutaneous use for the treatment of adults with acute hepatic porphyria (AHP). The approval came three months before the PDUFA date of Feb 20, 2020. Givosiran injection will be marketed by the trade name of Givlaari. This is the second RNA interference (RNAi) therapeutic of Alnylam approved by the FDA in the last sixteen months. The drug’s approval was based on positive results from the phase III ENVISION study, which showed that AHP patients treated with the same experienced 70% lesser porphyria attacks compared to placebo.
The company expects to achieve regulatory approval from the European Medicines Agency (EMA) for Givlaari (givosiran) in early 2020 for the treatment of AHP. It also plans to execute on U.S. and EU commercial launches throughout 2020.
Alnylam’s first-of-its-kind RNAi therapeutic for the treatment of the polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis in adults, Onpattro, is witnessing strong uptake since launch.
The company is also evaluating several other candidates. A few significant ones include vutrisiran (ALN-AAT02), the first investigational RNAi therapeutic targeting AAT with Alnylam’s enhanced stabilization chemistry plus (ESC+) GalNAc-conjugate technology. During the third quarter of 2019, the company continued enrollment in the HELIOS-A phase III study on vutrisiran (ALN-TTRsc02) for the treatment of hATTR amyloidosis with polyneuropathy. It expects to complete enrollment in the study in early 2020. In November, Alnylam initiated the HELIOS-B phase III study of vutrisiran.
Other candidates include ALN-CC5 in phase I/II being evaluated to treat complement-mediated diseases, cemdisiran in phase II to treat complement-mediated diseases and lumasiran in phase I/II to treat Primary Hyperoxaluria Type 1 (PH1).
In December, the company announced positive top-line results from the phase III study of lumasiran. The ILLUMINATE-A study met its primary efficacy endpoint and all tested secondary endpoints.
In April, Alnylam and Regeneron Pharmaceuticals (REGN - Free Report) extended their collaboration agreement. Both companies will work together to discover, develop and commercialize new RNAi therapeutics for a broad range of diseases by addressing disease targets expressed in the eye and central nervous system (CNS), in addition to a select number of targets expressed in the liver. The companies plan to advance programs directed to 30 targets. Other candidates also might be introduced into clinical developments during the initial five-year discovery period, which may extend.
Zacks Rank & Stocks to Consider
Alnylam is a Zacks Rank #3 (Hold) stock, currently.
A few better-ranked stocks in the biotech sector are Alkermes Plc. (ALKS - Free Report) and Innoviva Inc. (INVA - Free Report) , both sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Alkermes’’s earnings per share estimates have increased from 36 cents to 52 cents for 2019 in the past 90 days. The company delivered a positive earnings surprise in the trailing four quarters by 236.80%, on average.
Innoviva’s earnings per share estimates have increased from $1.71 to $2.03 for 2019 and from $1.07 to $1.34 for 2020 in the past 60 days.
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